The two companies announced a long-term commercial supply agreement for manufacture of the bulk substance in September 2010 when the product had completed its Phase III trials and have worked together to complete validation and establish a well characterised process.
Fujifilm Diosynth Biotechnologies is one of the world's leading providers of contract process development and manufacturing services for biopharmaceuticals and the UK business has been working with ThromboGenics for over seven years as the drug progressed through its clinical trials. This illustrates the value of long-term deep collaboration in securing both cost effective and timely commercialisation of such complex new medicines.
Steve Bagshaw, Managing Director of Fujifilm Diosynth Biotechnologies' Billingham, UK, said "we are delighted that ThromboGenics has received FDA approval for the launch of JETREA® in the USA. It is very gratifying for our team to see that their hard work in developing and manufacturing the product over the years has resulted in a drug being available to people suffering from distressing ophthalmic conditions. This is fifth licensed biopharmaceutical manufactured by Fujifilm Diosynth Biotechnologies and the second made at our Billingham site, demonstrating our growing expertise in helping to transition biopharmaceuticals from the clinic to become marketed new drugs".
Dr. Patrik De Haes, CEO of ThromboGenics said "Fujifilm Diosynth Biotechnologies has been a key partner in helping to bring our first drug to market. Their team at Billingham have done an excellent job in developing and validating a robust process and manufacturing material to enable us to launch the product on schedule".